Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184763
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-28
First Post:
2023-12-15
Brief Title:
Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR TEZACAFTOR IVACAFTOR
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR TEZACAFTOR IVACAFTOR
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMETI
Brief Summary:
The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients
The triple combination of CFTR modulators ELEXACAFTOR TEZACAFTOR IVACAFTOR has recently changed the management of cystic fibrosis
This treatment has been shown to rapidly improve patients respiratory function with a gain in FEV1 at 1 month ranging from 104 to 136 It also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients
To date there is limited data on the impact of these new therapies on physical activity Few studies have investigated changes in exercise or physical activity parameters under ELEXACAFTOR TEZACAFTOR IVACAFTOR
The 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases including cystic fibrosis
The triple combination of CFTR modulators ELEXACAFTOR TEZACAFTOR IVACAFTOR has recently changed the management of cystic fibrosis
This treatment has been shown to rapidly improve patients respiratory function with a gain in FEV1 at 1 month ranging from 104 to 136 It also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients
To date there is limited data on the impact of these new therapies on physical activity Few studies have investigated changes in exercise or physical activity parameters under ELEXACAFTOR TEZACAFTOR IVACAFTOR
The 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases including cystic fibrosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Easydore | OTHER | 69HCL23_1322 | None |